FindTrial
Sign In

Multinational, Interventional, 52-week, Open-label, Single-arm Study to Evaluate the Treatment Outcomes of Anifrolumab 120 mg Subcutaneous Once Weekly in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus (SUNFLOWER)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523670-17-00
Enrollment
55
Registered
2026-06-02
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic lupus erythematosus

Brief summary

Proportion of participants who are in DORIS remission at Week 52

Detailed description

1. Proportion of participants who are in LLDAS, or LLDAS- 5 at Week 28 and 52, 2. Proportion of time spent in DORIS remission, in LLDS and LLDAS-5, 3. Proportion of participants who achieve DORIS, LLDS and LLDAS-5 that is sustained for all subsequent visits up to and including Week 52, 4. Proportion of participants who achieve DORIS, LLDS and LLDAS-5 that is sustained for three or more consecutive visits, 5. Time to first DORIS, LLDS and LLDAS-5 that is sustained through to Week 52

Interventions

DRUGSaphnelo 120 mg solution for injection in pre-filled syringe

Sponsors

AstraZeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Proportion of participants who are in DORIS remission at Week 52—

Secondary

MeasureTime frame
1. Proportion of participants who are in LLDAS, or LLDAS- 5 at Week 28 and 52, 2. Proportion of time spent in DORIS remission, in LLDS and LLDAS-5, 3. Proportion of participants who achieve DORIS, LLDS and LLDAS-5 that is sustained for all subsequent visits up to and including Week 52, 4. Proportion of participants who achieve DORIS, LLDS and LLDAS-5 that is sustained for three or more consecutive visits, 5. Time to first DORIS, LLDS and LLDAS-5 that is sustained through to Week 52—

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 4, 2026